TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling 33 units of the TruClear Hysteroscopic Tissue Removal System Control Unit, a medical device designed for intrauterine tissue removal. The recall was issued due to electrical component failure within the control unit that causes a loss of function when the device is used with its handpiece and foot switch. The affected units were distributed across multiple U.S. states (Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington) as well as internationally in the United Kingdom, Ireland, Netherlands, Reunion, and Spain.
The recalled units have specific serial numbers ranging from YF1120 through YF1182, and the source document does not specify what remedy or corrective action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Reason for recall: Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. Distribution: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain Quantity: 33 units Lot/code info: UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.